Alpine Immune Sciences Announces First Subjects Dosed in Phase I Clinical Trial for Lead Autoimmune/Inflammatory Disease Program ALPN-101

The Associated Press

SEATTLE--(BUSINESS WIRE)--Feb 11, 2019--Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced successful initiation of dosing in its first-in-human Phase I study of ALPN-101, a first-in-class dual ICOS/CD28 antagonist.

This study will evaluate the safety and tolerability of single- and multiple-ascending intravenous and/or subcutaneous doses of ALPN-101. In addition, pharmacokinetics, pharmacodynamics, and exploratory biomarkers are being evaluated to help determine ALPN-101’s potential for the treatment of autoimmune and inflammatory diseases. The company expects data later in 2019.

“This first dosing in the initial clinical trial of ALPN-101 is an important milestone for Alpine as we have now transitioned to a clinical-stage development company,” stated Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. “We look forward to further exploring how our first-in-class dual ICOS/CD28 antagonist will potentially improve outcomes of patients suffering from debilitating autoimmune and inflammatory diseases such as GvHD and psoriatic arthritis.”

AIS-A01 is a randomized, placebo-controlled, blinded study in adult healthy volunteers to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single and multiple ascending doses of ALPN-101. The trial is being conducted in Australia. More information is available at www.clinicaltrials.gov (Identifier: NCT03748836).

Alpine Immune Sciences, Inc. is committed to leading a new wave of functional immune therapeutics. Alpine is employing directed evolution to create potentially powerful multifunctional immunotherapies to improve patients’ lives. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a dual ICOS/CD28 antagonist, engineered to reduce pathogenic immune responses. The second, ALPN-202 for cancer, is a dual PD-L1/CTLA-4 antagonist and PD-L1-dependent CD28 costimulator intended to combine checkpoint inhibition with T cell costimulation – an approach currently absent from approved checkpoint therapies. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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